EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10108/2022  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III  to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for isoxaben, 
novaluron and tetraconazole in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for isoxaben, 
novaluron and tetraconazole in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION , 
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the 
Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant a nd animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article  14(1) , point  (a), Article 18(1) , point (b), and Article 49(2) thereof,  
Whereas:  
(1) For isoxaben, novaluron and tetraconazole maximum residue levels ( ‘MRLs ’) were set 
in Part A of  Annex III to Regulation (EC) No 396/2005.  
(2) For isoxaben , the European Food Safety Authority (‘ the Authority ’) submitted a 
reasoned opinion on the review of the existing MRLs in accordance with Article  12(1) 
of Regulation (EC) No  396/20052. The Authority  recommended lower ing the existing 
MRLs for fruits and tree nuts , root and tuber vegetables, bulb vegetables, melons, 
pumpkins , witloof, chives, celery leaves, stem vegetables, oilseeds and oil fruits, 
cereals, and chicory roots , in line with the principle of setting MRLs at levels as low as 
reasonably achievable and based on sufficient supporting data for the current good 
agricultural practices (‘GAPs’) . It recommended keeping the existing MRLs  for 
courgettes and beans (fresh, without pods)  based on sufficient supporting data  for the 
current  GAPs . As there is no risk for consumers  with any of those MRLs , it is 
appropriate to set  the MRLs for those products in Annex  II to Regulation (EC) 
No 396/2005 at the level identified by the Authority.  
(3) For isoxaben, t he Authority further concluded that the MRLs for sage, rosemary, 
thyme, basil, cotton seed, herbal infusions (dried, flowers), herbal infusions (dried, 
roots), and hops  should be set at the current limits of determination (‘LOD’) specific 
to eac h product, in line with the principle of setting MRLs at levels as low as 
reasonably achievable  and based on the current GAPs. However, as  some information 
was not available , further consideration by risk managers was required.  While these 
MRLs are conside red safe, they  will therefore  be reviewed . The review will  take into 
account  the information available within two years from the publication of this 
Regulation.  As there is no risk for consumers, it is appropriate to set the MRLs for 
                                                 
1 OJ L 70, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for isoxaben  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2022;20(1):7062 .  
EN 2  EN those products at the LOD s specific to each product  in Annex  II to Regulation (EC) 
No 396/2005.  
(4) For novaluron , the Authority submitted a reasoned opinion on the review of the 
existing MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20053. In 
view of various data  gaps on toxicologically relevant issues, including uncertainties 
regarding possible endocrine disruptor properties  of that active substance, the 
Authority could not rule out harmful effects on human health with the MRLs for 
novaluron in all prod ucts. It is therefo re appropriate to set the MRLs  for all products  at 
the LOD s specific to each product  in Annex  II to Regulation (EC) No  396/2005.  
(5) For tetraconazole , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No 396/20054. It recommended 
keeping the existing MRL for kaki/Japanese persimmons  based on  sufficient 
supporting data for the current GAPs . As  there is no risk for consumers , it is 
appropriate to set the MRL for kaki/Japanese persimmons in Annex  II to Regulation 
(EC) No  396/2005 at the level identified by the Authority.  
(6) For tetraconazole , the Authority further concluded that the MRLs for loquats, apricots, 
peaches, table grapes, wine grapes, strawberries, cucumbers, gherkins, courgettes, rye, 
wheat, sugar beet root, products of animal origin except bovine liver and horse liver, 
and milks should be lowered in line with the principle of sett ing MRLs at levels as low 
as reasonably achievable and based on  the current GAPs. It concluded that the MRLs 
for apples, pears, quinces, medlars, peppers, witloofs, globe artichokes, linseeds, 
rapeseeds, barley, buckwheat, maize, millet, oat, rice, sorghum , and birds’ eggs should 
be maintained based on  the current GAPs. It further concluded that the MRLs for 
tomatoes, aubergines, melons, pumpkins, watermelons, chicory roots, bovine liver and 
horse liver should be raised based on  the current GAPs. However, a s some information 
was not available , further consideration by risk managers was required . While these 
MRLs are considered safe, they will therefore be reviewed . The review will  take into 
account the information available within two years from the publicat ion of this 
Regulation.  As there is no risk for consumers, it is appropriate to set the MRLs for 
those products  in Annex  II to Regulation (EC) No  396/2005 at the level s identified by 
the Authority . 
(7) The Authority  assessed the existing Codex maximum residue levels ( ‘CXLs ’) in its 
reasoned opinions . For setting the MRLs, t he Commission has taken into account 
those CXLs that are considered safe for consumers in the Union.  
(8) As regards products on which the use of plant protection product s containing the 
active substances isoxaben, novaluron or tetraconazole  is not authorised, and for 
which no import tolerances or CXLs exist, it is appropriate to set the MRLs at the 
specific LOD s, or the default MRL should apply  as provided for in Article  18(1) , point 
(b), of Regulation (EC) No  396/2005.  
                                                 
3 European Food Safety Authority; Reasoned opinion on t he review of the existing maximum residue 
levels for novaluron  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2022;20(1):7041 . 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for  isoxaben  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2022;20(1):7111 .  
EN 3  EN (9) The Commission consulted the European Union reference laboratories for residues of 
pesticides on the need to adapt certain LODs. For all the active substances covered by 
this Regulation , those laboratories proposed product specific LODs.  
(10) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(11) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(12) For isoxaben and tetraconazole , to allow for the normal marketing, processing and 
consumption of products, this Regulation should not apply  to products , which have 
been produced  in the Union or imported into the Union  before  the new MRLs  become 
applicable  and for which a high level of consumer protection is maintained.  
(13) A reasonable period should be allowed to elapse before the new MRLs become 
applicable , in order to permit Member States, third countries and food business 
operators to adapt themselves to the re quirements which result from the modification 
of the MRLs.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II  and III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
As regards the active substances isoxaben and tetraconazole  in and on all products, 
Regulation (EC) No 396/2005 as it stood before being amended by this  Regulation shall 
continue to apply to products which were produced in the Union or imported into the Union 
before … [Office of Publications: please insert date 6  months after entry into force of this 
Regulation ].  
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
It shall apply from … [Office of Publication: please insert date 6 months after entry into 
force ]. 
This Regulation  shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN